The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Compress Distal Femoral Replacement System.
| Device ID | K041352 |
| 510k Number | K041352 |
| Device Name: | COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304443013 | K041352 | 000 |
| 00880304260733 | K041352 | 000 |
| 00880304260740 | K041352 | 000 |
| 00880304260757 | K041352 | 000 |
| 00880304430655 | K041352 | 000 |
| 00880304430792 | K041352 | 000 |
| 00880304430839 | K041352 | 000 |
| 00880304430846 | K041352 | 000 |
| 00880304430853 | K041352 | 000 |
| 00880304260320 | K041352 | 000 |